The United States Food and Drug Administration (USFDA) has issued three observations to Dr. Reddy's Laboratories following an inspection at its FTO-9 manufacturing facility in Visakhapatnam, Andhra Pradesh.
This Pre-Approval Inspection (PAI) by the USFDA took place over two days, from October 8 to 9, 2026, at the company's plant.
According to the regulatory filing made by Dr. Reddy's Laboratories, the USFDA communicated these findings through a Form 483, which details the inspectional observations.
The company is now expected to address these observations from the USFDA regarding its Visakhapatnam facility. Further actions will be taken based on the company's response.
